BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIEZON MASTER SURGERY TIP

    MDR report key: 1016370 · Received March 6, 2008

    Report

    Report Number
    8030987-2008-00001
    Event Type
    Other
    Date Received
    March 6, 2008
    Date of Event
    January 29, 2008
    Report Date
    May 3, 2008
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    DZI
    PMA / PMN Number
    K072146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN TIP DS-102 HAS BEEN RETURNED FOR EXAMINATION. THE BREAKAGE OF THE INSTRUMENT AND THE REMAINING OF THE BROKEN PART IN THE TREATED TISSUES HAS BEEN IDENTIFIED IN THE EMS'S RISK'S ASSESSMENT. IT HAS BEEN CLASSIFIED AS TOLERABLE.

    Description of Event or Problem · 1

    (AFFILIATE) HAS BEEN INFORMED FEBRUARY 05 2008 BY A DR, OF AN INCIDENT THAT OCCURRED IN OTHER COUNTRY, DURING AN INTERVENTION IN COMBINATION WITH THE PIEZON MASTER SURGERY DEVICE. DR. STATED AS FOLLOWS: ON THE PREVIOUS MONTH, DR UNDERTOOK THE POSITIONING OF TWO IMPLANTS WITH DIRECT SINUSLIFT ON A PATIENT. WHILE POLISHING THE BRINK OF THE BONE AT SINUS MAXILLARIES (RIGHT SIDE), THE SL2 (TIP DS-102) FRACTURED. THE BROKEN PIECE UNFORTUNATELY SLIDED THROUGH THE MEMBRANE INTO THE MAXILLARY AIR SINUS. THE REMOVAL OF THE FOREIGN MATERIAL FROM THE RIGHT MAXILLARY AIR SINUS CAN ONLY TAKE PLACE AFTER THE HEALING OF THE SCREWED-IN IMPLANTS. (STATE 15.02.08 ACCORDING TO LETTER DR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZON MASTER SURGERY TIP ULTRASONIC DENTAL SURGICAL SYSTEM TIP DZI E.M.S. ELECTRO MEDICAL SYSTEMS S.A. DS-102 2XA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention